| CTRI Number |
CTRI/2023/02/049600 [Registered on: 09/02/2023] Trial Registered Prospectively |
| Last Modified On: |
07/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the ratio of arm and leg blood pressures between diabetic and normal individuals of same age. |
|
Scientific Title of Study
|
Comparison of Ankle Brachial Index among diabetic and non diabetic age matched individuals. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jaimala Shetye |
| Designation |
Assistant professor |
| Affiliation |
P.T.School and centre,Seth GS Medical college and KEM hospital |
| Address |
P.T.School and centre,Seth GS Medical college and KEM hospital,Acharya Dhonde Marg,Parel (E),Mumbai
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
02224143435 |
| Fax |
|
| Email |
jaimalavs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jaimala Shetye |
| Designation |
Assistant professor |
| Affiliation |
P.T.School and centre,Seth GS Medical college and KEM hospital |
| Address |
P.T.School and centre,Seth GS Medical college and KEM hospital,Acharya Dhonde Marg,Parel (E),Mumbai
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
02224143435 |
| Fax |
|
| Email |
jaimalavs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rutuja Wayal |
| Designation |
Master of Physiotherapy |
| Affiliation |
P.T.School and centre,Seth GS Medical college and KEM hospital |
| Address |
P.T.School and centre,Seth GS Medical college and KEM hospital,Acharya Dhonde Marg,Parel (E),Mumbai
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
9702397236 |
| Fax |
|
| Email |
rutujawayal17@gmail.com |
|
|
Source of Monetary or Material Support
|
| P.T.School and Centre,Seth GS Medical College and KEM Hospital,Parel(E),Mumbai-12 |
|
|
Primary Sponsor
|
| Name |
Jaimala Shetye |
| Address |
P.T.School and Centre,Seth GS Medical College and KEM Hospital,Parel(E),Mumbai-12 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Jaimala Shetye |
P.T.School and Centre,Seth GS Medical College and KEM |
Medicine OPD no 26,1st floor,New building,KEM hospital,Acharya Dhonde Marg,Parel(E),Mumbai-12
Mumbai (Suburban)
MAHARASHTRA |
02224143435
jaimalavs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Seth GS Medical College and KEM Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Group A :- Asymptomatic type 2 Diabetic individual
between 40-60 years of age with DM duration of more
than 5 years including both the gender.
Group B:- Non diabetic individuals between 40-60 years of age including both the gender. |
|
| ExclusionCriteria |
| Details |
1. Contraindication to brachial &/or ankle pressure measurement including history of DVT , lymphoedema of arm or legs.
2. History of mastectomy or current leg ulceration and inability to lie supine.
3. Any other condition causing PAD other than diabetes like Buerger’s disease. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ankle Brachial Index |
Once(Baseline ) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Skin temperature |
Once(Baseline) |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/02/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Ankle brachial index (ABI) is widely used for determining the presence and severity of peripheral arterial disease (PAD) and current guidelines suggest it should be used to monitor possible progression in affected individual. Existing studies suggest the ABI is reliable in general population however, there is a lack of evidence for its association in people with diabetes. It is a comparative study which will require 30mins/per participant. Participants fulfilling inclusion and exclusion criteria will be enrolled, The ABI is a non-invasive method and is typically calculated as the ratio of the highest of the dorsalis pedis and posterior tibial artery systolic pressure to the highest of the left and right brachial systolic pressures using a minidop ES-100VX(Hadeco) hand held vascular doppler The cuff position will be ensured for it to be at the heart level. All BP will be measured once, with a minimum of 3 minutes between pressure measurements. For measuring brachial pressures place the ultrasound gel in the antecubital fossa over the patient’s brachial pulse. Place the transducer of the handheld Doppler on the gel, and position the transducer to maximize the intensity of the signal. Inflate the cuff to about 20 mmHg above the expected systolic blood pressure of the patient. The Doppler signal should disappear. Then slowly deflate the cuff, approximately 1 mmHg/sec. When the Doppler signal re-appears, the pressure of the cuff is equal to the brachial systolic pressure. Record the brachial systolic pressure. Similarly the Doppler signal of the dorsalis pedis is often been found slightly lateral to the midline of the dorsum of the foot and posterior tibial signal is detected posterior to the medial malleolus. Normal value for ABI assessment within the general population is considered to be 1.00–1.40, with values 0.91–0.99 classed as ‘borderline’, while those below 0.91 represent likely PAD.ABI of both groups of Asymptomatic type 2 Diabetic individuals between 40-60 of age with DM duration of more than 5 years and Non-diabetic individuals between 40- 60 of age including both the genders will be compared. Individuals with contraindication to brachial &/or ankle pressure measurement including history of DVT , lymphoedema of arm or legs ,history of mastectomy or current leg ulceration and inability to lie supine. Any other condition causing PAD other than diabetes like Buerger’s disease will be excluded. Total sample size is 46,with 23 in each group. Analysis of the data will be done using appropriate statistical test. |